The board of directors of Sino Biopharmaceutical Limited announced that clinical trial for the treatment of pneumoconiosis with the Category I innovative medicine "TDI01" suspension self-developed by the Group has been approved by the National Medical Products Administrations of China. TDI01 is an inhibitor acting on new target of Rho/Rho associated coiled-coil containing protein kinase 2 (ROCK2) with high selectivity, and a "significant new drug" of the 13th Five-Year Plan of China. The Phase I clinical trial of the innovative medicine has been completed in the United States with a good safety profile, and a bridge study is currently being carried out in China.

TDI01 was previously approved for clinical trial in China for the treatment of idiopathic pulmonary fibrosis, and pneumoconiosis is its second indication approved for clinical trial. The Group will continue to explore its application in fibrosis and related areas. Pneumoconiosis is a systemic disease caused by diffuse fibrosis (scarring) of the lung tissue due to the inhalation of industrial dust (dust) over a long period of time during occupational activities and the retention of dust in the lungs.

It causes symptoms such as coughing, chest tightness, shortness of breath and difficulty in breathing, and has a serious impact on pulmonary function of patients. At present, there is no effective medicine and measures for treatment in both China and overseas. TDI01 has shown significant improvement in pathological score and pulmonary function in pneumoconiosis models and the Group will actively advance the progress of the human clinical trial of TDI01.